摘要
目的研制新型镍钛记忆合金硅橡胶立式网状宫内节育器（NTDR—IUD），观察NTDR-IUD的安全性、耐腐蚀及应变性。方法NTDR-IUD所用材料为镍钛记忆合金丝，编织成网格状支架，外包硅橡胶。进行NTDR．IUD软化点调节实验，确定记忆合金丝材的组成比例、定型实验，NTDR—IUD涂膜及生物学、物理、化学性能评价。模拟官腔内环境下进行耐腐蚀及应变性试验，体外进行黏膜刺激、毒性、溶血、热源实验及肌内植入实验。结果研制出NTDR—IUD，为三维立体网状结构，其支架为镍钛合金丝，镍钛合金丝外面包绕一层硅橡胶（涂膜），具有弹性，丝的横截面直径为0．1—0．5mm，外形是网状立体结构，呈心形或倒梨形，上端横径长度2．0—3．5cm，下端横径长度1．0～2．0cm，支架厚度0．3—0．8cm。镍钛记忆合金支架在25℃以下缩形为直线状，在体温36—37℃恢复其结构；硅橡胶涂膜防止镍钛合金丝与组织粘连。NTSR—IUD耐腐蚀性能试验1年后镍钛合金丝的应力和应变性能没有明显的变化，镍钛合金丝在模拟官腔液中是稳定的；各种性能指标均达到规定的质量要求。黏膜刺激试验、毒性试验、溶血实验、热源实验及肌内植入实验均未发现异常。结论NTDR—IUD具有很好的耐腐蚀性、变应能力和安全性，可为育龄人群提供新的避孕节育器械。
Objective To develop a new three-dimensional and reticular intrauterine device （NTDR-IUD） with nickel-titanium （Ni-Ti） wire and silicone rubber, and to assess its safety, corrosion resistance, and contingency. Methods The device was made from nitinol wire and the silicone rubber. Biological, physical, and chemical characteristics of the device were assessed. Corrosion resistance test and strain test were carried out under the simulated intrauterine environment. Mucosal irritation test, toxicity, hemolysis, and heat experiment were performed. Results The device was developed with a three-dimensional and reticular structure. The diameter of the nitinol wire was 0.1-0.5 mm. The device was heart-shaped or inverted pear-shaped. The length of the top diameter, the length of the bottom diameter, and the thickness of device was 2.0-3.5 cm, 1.0-2.0 cm and 0.3-0.8 cm, respectively. The stent of Ni-Ti memory alloy wire was shrunk with linear shape at temperature below 25 ℃, and was restored to the designed structure at 36-37 ℃. To prevent tissue adhesion, the surface of the frame was coated with a layer of silicone rubber. There was no significant change in the stress and strain properties of nickel titanium wire after one year corrosion experiment. The Ni-Ti wire in simulated uterine fluid was stable. Various performance indicators of the device met the prescribed quality requirements. The mucous membrane irritation test, toxicity test, hemolysis test, pyrogen test, and muscular implant test were normal. Conclusion The NTDR-IUD was safe and resistant to corrosion; it may be used as a new contraceptive device for women of childbearing age.
出处
《中国生育健康杂志》
2013年第1期43-46,F0003,共5页
Chinese Journal of Reproductive Health
基金
山东省计划生育科学技术研究项目（2009-1）
关键词
宫内节育器
镍钛记忆合金丝
研制
安全性
Intrauterine device
Contraception
Nitinol mesh and silicon rubber
Safety
